Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shionogi
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects aged 18 to 80 years inclusive at the time of informed consent
Subjects must have non-malignant chronic pain treated with opioids and must have opioid-induced constipation (OIC)
Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate
Subjects must not be currently using laxatives or must be willing to discontinue laxative use at Screening and must be willing to use only the rescue laxatives provided throughout the study duration
Subjects must meet opioid-induced constipation criteria based on the Bowel Movement and Constipation Assessment (BMCA) Diary
You may not be if
Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
Evidence of active medical diseases affecting bowel transit
History or presence of pelvic disorders that may be a cause of constipation
Surgery (except for minor procedures) within 60 days of Screening
History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical GI obstruction)
Subjects who have never taken laxatives for the treatment of OIC
History of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen \[Nolvadex®\] and raloxifene \[Evista®\] when being used for prevention of breast cancer
Current use of any prohibited medication including opioid antagonists, partial agonists, or mixed agonists/antagonists
